Lumisight FDA Approval History
Last updated by Judith Stewart, BPharm on April 23, 2024.
FDA Approved: Yes (First approved April 17, 2024)
Brand name: Lumisight
Generic name: pegulicianine
Dosage form: for Injection
Company: Lumicell, Inc.
Treatment for: Diagnosis and Investigation
Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.
- Lumpectomy surgery for breast cancer can often result in incomplete removal of the tumor. Lumisight is used with the Lumicell Direct Visualization System (DVS) fluorescence imaging device to detect any residual cancerous tissue within the lumpectomy cavity following removal of the primary tumor, potentially sparing some patients from a second surgery.
- Lumisight contains pegulicianine, an optically inactive prodrug that works to illuminate any residual cancerous tissue by producing a fluorescent signal after its peptide chain is cleaved by certain enzymes that have higher levels in and around tumor and tumor-associated cells compared to normal cells.
- Lumisight is administered by intravenous injection over 3 minutes, 2 hours to 6 hours prior to imaging.
- Lumisight carries a Boxed Warning for serious hypersensitivity reactions, including anaphylaxis. Warnings and precautions associated with Lumisight include a risk of misdiagnosis and interference from dyes used for sentinel lymph node mapping.
- Common adverse reactions (≥1%) include hypersensitivity and chromaturia (abnormal color in urine).
Development timeline for Lumisight
Further information
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